Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

Completed

Phase 2 Results N/A

Trial Description

This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Saline injection on Day 0
    ARM 1: Kind: Experimental
    Label: 2
    Description: Saline
  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: 200 U to 360 U of botulinum toxin Type A on Day 0. Patients who met retreatment criteria received a second treatment (open-label) at Week 12 or Week 18
    ARM 1: Kind: Experimental
    Label: 1
    Description: Botulinum Toxin Type A

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit) Week 6 No
Secondary Spasticity of the upper-limb flexors as measured by the Ashworth Scale Week 6 No

Sponsors